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1. Surgical Performance Determines Functional Outcome Benefit in the Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) Procedure

Author

Andras Buki, Ludwig Schuerer, Barbara A. Gregson, Joshua N. Goldstein, Jared Knopman, Alexandra D Baker, Ashutosh P Jadhav, Laszlo Csiba, Terry Quinn, Kristi Tucker, Gayane Yenokyan, E. Francois Aldrich, Richard E. Thompson, John Laidlaw, Steven Mayo, Alastair Wilson, Michael L. James, Krista Vermillion, Andreas Unterberg, Fernando Muñoz Hernandez, Karin Jonczak, Jesse Dawson, Alejandro Carrasco Gonzalez, Jamie Braun, Rishi Malhorta, Lisa Yanase, Hua Feng, Craig S. Anderson, Ying Cao, Michael Rosenblum, Roddy O'Kane, Jeffrey S. Schweitzer, Krishna K. Mohan, Robert Hoesch, Robert D. Ecker, Rong Hu, Cian O'Kelly, Nader Pouratian, Igor Rybinnik, Yi Huang, Julius Gene Latorre, Peter Brindley, Scott Janis, Huy Tran, Weimin Wang, Mohammed Rehman, Nataly Montano Vargas, Zhiyuan Yu, Tiffany R. Chang, Christianto B. Lumenta, Rosario Sarabia, Paul M. Vespa, David Antezana, Keith W. Muir, Ying Wang, Kennedy R. Lees, Thomas Kerz, Steven J. Barrer, Safdar Ansari, Elizabeth A. Sugar, Louis Tony Whitworth, Romuald Girard, Thomas A. Bergman, Myriha Wrencher, Gaurav Gupta, Krissia Rivera Perla, Judy Huang, Doug Anderson, Joshua Betz, Ryan S. Kitagawa, Mohammed Hussain, Marcelino Báguena, Sepideh Amin-Hanjani, Krisztian Tanczos, Avinash B. Kumar, Brian L. Hoh, W. David Freeman, Tracey Economas, Dheeraj Gandhi, Mary Leigh Gelea, Hiren C. Patel, Esther Jeon, Byron Willis, Gonzalo Tamayo, Saman Nekoovaght-Tak, Lior Ungar, Ahmed Maswadeh, Adrian R Parry-Jones, Marc D. Malkoff, Michael Abraham, Carlos Alarcon Alba, Michael R. Chicoine, George A. Lopez, Jeanne Teitelbaum, Scott McCaul, Walter Galicich, David Schel, Ryan Majkowski, Douglas Franz, Agnieszka Ardelt, Issam A. Awad, Yunke Li, Hasan Ali, Satish Krishnamurthy, Yi Hao, Geza Mezey, Amal Abou-Hamden, James Leiphart, Xuxia Yi, Darren Lovick, Colin P. Dierdeyn, Jack Jallo, Jennifer Houser, Vikram Madan, Julián Carrión-Penagos, Jean-Louis Caron, Paul J. Camarata, Nichol McBee, Ania Pollack, Lorenzo F. Munoz, Sarah Lenington, Lauren H Sansing, Kathrine Thomas, Alberto Torres Díaz, Joel D. MacDonald, J. Ricardo Carhuapoma, Pedro Enriquez, Janet Mighty, Salvatore Insinga, Ottó Major, Steven M. Greenberg, Jinbiao Luo, Jennifer Jaffe, W. Andrew Mould, Cully Cobb, Sagi Harnof, Robert F James, Yan Wang, Ali R. Zomorodi, David B. Seder, Ventatakrishna Rajajee, Arun Lakhanpal, Robert H. Brown, Yongge Xu, Karen Lane, Naureen Keric, A. David Mendelow, David Ledoux, Azmil Abdul-Rahim, Babak S. Jahromi, Janne Koskimäki, Chitra Venkatasubramanian, Dennis G. Vollmer, Charles C. Matouk, William C. Broaddus, Julio A. Chalela, Fred Rincon, Sean P. Polster, Kevin N. Sheth, Patrick Mitchell, Daryl R. Gress, Daniel F Hanley, Bing Cao, Indalecio Moran Chorro, Mario Zuccarello, Maged D Fam, Carolyn Koenig, Aditya S. Pandey, Patricia Lynn Money, Christiana E. Hall, Baltasar Sanchez, Kesava Reddy, Hartmut Vatter, Robert L. Dodd, Panos Varelas, James C. Torner, Michael Schneck, Christina Grabarits, Azam Ahmed, Diederik Bulters, Paul A. Nyquist, Michael N. Diringer, Jason M Davies, Radhika Avadhani, Ben Jonker, Katalin Szabo, Agnieszka Stadnik, Donald Seyfried, Brian T. Jankowitz, Joshua E. Medow, Erzsebet Ezer, Pál Barzó, Luisa Corral, Inam Kureshi, Ronald Reimer, David Altschul, Fuat Arikan, Alex Nee, Stacey Q Wolfe, Mohamed Okasha, Matthew B. Maas, Mark R. Harrigan, John Terry, Natalie Ullman, Dana Leifer, Yuhua Fan, Jiajun Wen, Gregory Thompson, Alejandro M Spiotta, Amanda J. Bistran-Hall, Fernando D. Testai, Noeleen Ostapkovich, Eugene Gu, Kyra J. Becker, David Miller, Carlos S. Kase, Carol B. Thompson, Shawn E. Wright, Wendy C. Ziai, Philipp Taussky, Peter Nakaji, Nicki Karlen, Halinder S. Mangat, Andrew P. Carlson, Shakeel A. Chowdhry, Azize Boström, Rachel Dlugash, Michael T. Stechison, Kate McArthur, Larami MacKenzie, Matthew R. Fusco, and Draga Jichici

Subjects
Male, medicine.medical_specialty, law.invention, 03 medical and health sciences, 0302 clinical medicine, Hematoma, Fibrinolytic Agents, Randomized controlled trial, Modified Rankin Scale, law, medicine, Humans, Minimally Invasive Surgical Procedures, cardiovascular diseases, Research—Human—Clinical Trials, Intraparenchymal hemorrhage, Stroke, Aged, Intracerebral hemorrhage, business.industry, Recovery of Function, Middle Aged, medicine.disease, Combined Modality Therapy, Surgery, Treatment Outcome, Tissue Plasminogen Activator, 030220 oncology & carcinogenesis, Emergency evacuation, Female, Neurology (clinical), business, Intracranial Hemorrhages, 030217 neurology & neurosurgery, Fibrinolytic agent
Abstract

Background Minimally invasive surgery procedures, including stereotactic catheter aspiration and clearance of intracerebral hemorrhage (ICH) with recombinant tissue plasminogen activator hold a promise to improve outcome of supratentorial brain hemorrhage, a morbid and disabling type of stroke. A recently completed Phase III randomized trial showed improved mortality but was neutral on the primary outcome (modified Rankin scale score 0 to 3 at 1 yr). Objective To assess surgical performance and its impact on the extent of ICH evacuation and functional outcomes. Methods Univariate and multivariate models were used to assess the extent of hematoma evacuation efficacy in relation to mRS 0 to 3 outcome and postulated factors related to patient, disease, and protocol adherence in the surgical arm (n = 242) of the MISTIE trial. Results Greater ICH reduction has a higher likelihood of achieving mRS of 0 to 3 with a minimum evacuation threshold of ≤15 mL end of treatment ICH volume or ≥70% volume reduction when controlling for disease severity factors. Mortality benefit was achieved at ≤30 mL end of treatment ICH volume, or >53% volume reduction. Initial hematoma volume, history of hypertension, irregular-shaped hematoma, number of alteplase doses given, surgical protocol deviations, and catheter manipulation problems were significant factors in failing to achieve ≤15 mL goal evacuation. Greater surgeon/site experiences were associated with avoiding poor hematoma evacuation. Conclusion This is the first surgical trial reporting thresholds for reduction of ICH volume correlating with improved mortality and functional outcomes. To realize the benefit of surgery, protocol objectives, surgeon education, technical enhancements, and case selection should be focused on this goal.

Published
2019
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2. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial

Author

Daniel F Hanley, Richard E Thompson, Michael Rosenblum, Gayane Yenokyan, Karen Lane, Nichol McBee, Steven W Mayo, Amanda J Bistran-Hall, Dheeraj Gandhi, W Andrew Mould, Natalie Ullman, Hasan Ali, J Ricardo Carhuapoma, Carlos S Kase, Kennedy R Lees, Jesse Dawson, Alastair Wilson, Joshua F Betz, Elizabeth A Sugar, Yi Hao, Radhika Avadhani, Jean-Louis Caron, Mark R Harrigan, Andrew P Carlson, Diederik Bulters, David LeDoux, Judy Huang, Cully Cobb, Gaurav Gupta, Ryan Kitagawa, Michael R Chicoine, Hiren Patel, Robert Dodd, Paul J Camarata, Stacey Wolfe, Agnieszka Stadnik, P Lynn Money, Patrick Mitchell, Rosario Sarabia, Sagi Harnof, Pal Barzo, Andreas Unterberg, Jeanne S Teitelbaum, Weimin Wang, Craig S Anderson, A David Mendelow, Barbara Gregson, Scott Janis, Paul Vespa, Wendy Ziai, Mario Zuccarello, Issam A Awad, Azmil Abdul-Rahim, Amal Abou-Hamden, Michael Abraham, Azam Ahmed, Carlos Alarcon Alba, E. Francois Aldrich, David Altschul, Sepideh Amin-Hanjani, Doug Anderson, Safdar Ansari, David Antezana, Agnieszka Ardelt, Fuat Arikan, Marcelino Baguena, Alexandra Baker, Steven J. Barrer, Kyra J. Becker, Thomas Bergman, Azize Boström, Jamie Braun, Peter Brindley, William C. Broaddus, Robert Brown, Andras Buki, Bing Cao, Ying Cao, Julian Carrion-Penagos, Julio Chalela, Tiffany Chang, Indalecio Moran Chorro, Shakeel Chowdhry, Luisa Corral, Laszlo Csiba, Jason Davies, Alberto Torres Díaz, Colin P. Derdeyn, Michael Diringer, Rachel Dlugash, Robert Ecker, Tracey Economas, Pedro Enriquez, Erzsebet Ezer, Yuhua Fan, Hua Feng, Douglas Franz, W. David Freeman, Matthew Fusco, Walter Galicich, Mary Leigh Gelea, Joshua Goldstein, Alejandro Carrasco Gonzalez, Christina Grabarits, Steven Greenberg, Daryl Gress, Eugene Gu, Christiana Hall, Fernando Muñoz Hernandez, Robert Hoesch, Brian L. Hoh, Jennifer Houser, Rong Hu, Yi Huang, Mohammed Akbar Hussain, Salvatore Insinga, Ashutosh Jadhav, Jennifer Jaffe, Babak S. Jahromi, Jack Jallo, Michael James, Robert F. James, Brian Jankowitz, Esther Jeon, Draga Jichici, Karin Jonczak, Ben Jonker, Nicki Karlen, Naureen Keric, Thomas Kerz, Jared Knopman, Carolyn Koenig, Satish Krishnamurthy, Avinash Kumar, Inam Kureshi, John Laidlaw, Arun Lakhanpal, Julius Gene Latorre, Dana Leifer, James Leiphart, Sarah Lenington, Yunke Li, George Lopez, Darren Lovick, Christianto Lumenta, Jinbiao Luo, Matthew B. Maas, Joel MacDonald, Larami MacKenzie, Vikram Madan, Ryan Majkowski, Otto Major, Rishi Malhorta, Marc Malkoff, Halinder Mangat, Ahmed Maswadeh, Charles Matouk, Kate McArthur, Scott McCaul, Joshua Medow, Geza Mezey, Janet Mighty, David Miller, Krishna K. Mohan, Keith Muir, Lorenzo Muñoz, Peter Nakaji, Alex Nee, Saman Nekoovaght-Tak, Paul Nyquist, Roddy O'Kane, Mohamed Okasha, Cian O'Kelly, Noeleen Ostapkovich, Aditya Pandey, Adrian Parry-Jones, Krissia Rivera Perla, Ania Pollack, Sean Polster, Nader Pouratian, Terry Quinn, Ventatakrishna Rajajee, Kesava Reddy, Mohammed Rehman, Ronald Reimer, Fred Rincon, Igor Rybinnik, Baltasar Sanchez, Lauren Sansing, Michael Schneck, Ludwig Schuerer, David Schul, Jeffrey Schweitzer, David B. Seder, Donald Seyfried, Kevin Sheth, Alejandro Spiotta, Michael Stechison, Katalin Szabo, Gonzalo Tamayo, Krisztian Tanczos, Philipp Taussky, John Terry, Fernando Testai, Kathrine Thomas, Carol B. Thompson, Gregory Thompson, James C. Torner, Huy Tran, Kristi Tucker, Lior Ungar, Panos Varelas, Nataly Montano Vargas, Hartmut Vatter, Chitra Venkatasubramanian, Krista Vermillion, Dennis Vollmer, Yan Wang, Ying Wang, Jiajun Wen, Louis Tony Whitworth, Byron Willis, Myriha Wrencher, Shawn E. Wright, Yongge Xu, Lisa Yanase, Xuxia Yi, Zhiyuan Yu, and Ali Zomorodi

Subjects
Male, medicine.medical_specialty, Catheters, medicine.medical_treatment, Population, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Clinical trials, Randomized controlled trial, Modified Rankin Scale, law, Internal medicine, medicine, Mortalitat, Humans, Minimally Invasive Surgical Procedures, Thrombolytic Therapy, 030212 general & internal medicine, Mortality, education, Stroke, Aged, Cerebral Hemorrhage, education.field_of_study, Intention-to-treat analysis, business.industry, Glasgow Coma Scale, Catèters, General Medicine, Odds ratio, Thrombolysis, Middle Aged, Infart cerebral, medicine.disease, Intention to Treat Analysis, Treatment Outcome, Cerebral infarctio, Female, business, Assaigs clínics
Abstract

Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage. MISTIE III was an open-label, blinded endpoint, phase 3 trial done at 78 hospitals in the USA, Canada, Europe, Australia, and Asia. We enrolled patients aged 18 years or older with spontaneous, non-traumatic, supratentorial intracerebral haemorrhage of 30 mL or more. We used a computer-generated number sequence with a block size of four or six to centrally randomise patients to image-guided MISTIE treatment (1·0 mg alteplase every 8 h for up to nine doses) or standard medical care. Primary outcome was good functional outcome, defined as the proportion of patients who achieved a modified Rankin Scale (mRS) score of 0-3 at 365 days, adjusted for group differences in prespecified baseline covariates (stability intracerebral haemorrhage size, age, Glasgow Coma Scale, stability intraventricular haemorrhage size, and clot location). Analysis of the primary efficacy outcome was done in the modified intention-to-treat (mITT) population, which included all eligible, randomly assigned patients who were exposed to treatment. All randomly assigned patients were included in the safety analysis. This study is registered with ClinicalTrials.gov, number NCT01827046. Between Dec 30, 2013, and Aug 15, 2017, 506 patients were randomly allocated: 255 (50%) to the MISTIE group and 251 (50%) to standard medical care. 499 patients (n=250 in the MISTIE group; n=249 in the standard medical care group) received treatment and were included in the mITT analysis set. The mITT primary adjusted efficacy analysis estimated that 45% of patients in the MISTIE group and 41% patients in the standard medical care group had achieved an mRS score of 0-3 at 365 days (adjusted risk difference 4% [95% CI -4 to 12]; p=0·33). Sensitivity analyses of 365-day mRS using generalised ordered logistic regression models adjusted for baseline variables showed that the estimated odds ratios comparing MISTIE with standard medical care for mRS scores higher than 5 versus 5 or less, higher than 4 versus 4 or less, higher than 3 versus 3 or less, and higher than 2 versus 2 or less were 0·60 (p=0·03), 0·84 (p=0·42), 0·87 (p=0·49), and 0·82 (p=0·44), respectively. At 7 days, two (1%) of 255 patients in the MISTIE group and ten (4%) of 251 patients in the standard medical care group had died (p=0·02) and at 30 days, 24 (9%) patients in the MISTIE group and 37 (15%) patients in the standard medical care group had died (p=0·07). The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six [2%] of 255 patients vs three [1%] of 251 patients; p=0·33 for symptomatic bleeding; two [1%] of 255 patients vs 0 [0%] of 251 patients; p=0·16 for brain bacterial infections). At 30 days, 76 (30%) of 255 patients in the MISTIE group and 84 (33%) of 251 patients in the standard medical care group had one or more serious adverse event, and the difference in number of serious adverse events between the groups was statistically significant (p=0·012). For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. The procedure was safely adopted by our sample of surgeons. National Institute of Neurological Disorders and Stroke and Genentech. [Abstract copyright: Copyright © 2019 Elsevier Ltd. All rights reserved.]

Published
2019

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